Potential Loss of Device Functionality Lower Risk Subset

Amplia, Claria, Compia, and Viva CRT-D, and Evera and Visia ICDOriginal Date of Communication:
March 2018

Product

In January 2018, Medtronic completed notification to physicians about a subset of 48 Medtronic Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and Implantable Cardioverter Defibrillators (ICDs) underwent a specific sequence of manufacturing processes that could result in an unexpected loss of device functionality, including high-voltage therapy.

Within this Lower-Risk Subset of 752 devices, if the device delivered the maximum number of shocks until battery depletion, we estimate 0.5% of these devices would experience arcing during high voltage charging, with failure occurring within the first two (2) high-voltage charges in 0.18% of the devices. See table below for comparison of device subsets.

Through 8 March 2018, there had been zero (0) complaints related to internal arcing in these 752 devices. While the risk for failure is lower in this group of devices, it is not possible to identify which of these 752 devices may fail or when they may fail. Successful delivery of previous high-voltage therapy does not ensure future performance.

You may use the "Search for Information by Serial Number" tool on home page of this web site to determine if a specific device is affected.

Table – Device Subsets

January 2018
48 Implanted Higher-Risk Devices

March 2018
752 Lower-Risk Devices

One field failure has been observed with no deaths reported

7.7% of these devices are projected to fail during the first two high-voltage charges

No field failures have been observed

0.18% of these devices are projected to fail during the first two high-voltage charges

Medtronic communicated a recommendation to strongly consider prophylactic replacement in these devices.

Patient management recommendations follow below.

Patient Management Recommendations – Lower Risk Subset

We realize that each patient requires unique clinical considerations. In consultation with Medtronic’s Independent Physician Quality Panel (IPQP), Medtronic provides the following recommendations to physicians for patients who have been implanted with one of the identified devices:

Prophylactic device replacement should be considered for patients at higher risk, including patients whose clinical history indicates prior need for high-voltage therapy and/or for pacemaker-dependent patients.

Physicians should carefully weigh the risks and benefits of device replacement. The estimated per patient risk for mortality due to this issue is 0.02% to 0.04% considering the risk of device failure and the likelihood of a patient requiring high voltage therapy. This is comparable to the estimated per patient mortality risk of complications associated with a device replacement (0.04%)[i],[ii].

For patients in whom it is determined that replacement is not warranted:

Consider programming changes to reduce the potential for high-voltage charges associated with arrhythmia detection and therapies, such as enabling ATP before charging for fast ventricular rhythms or programming a separate fast VT via VF zone with ATP. For assistance with patient-specific programming needs, contact Medtronic Technical Services at 800-723-4636.

­Continue three-month in-clinic or remote follow-ups to verify device functionality. Inability to interrogate a device or a failed remote monitoring transmission may be an indication that internal arcing has occurred. Devices that have failed will not send an alert as telemetry and all device functionality is immediately lost if internal arcing occurs.

Advise patients to seek medical attention immediately if they experience new or unexpected symptoms suspicious for a ventricular arrhythmia.

STATUS UPDATE - MAY 2020

Within the 752 lower-risk devices, there have been zero confirmed failures (0%) through April 22, 2020. An estimated 508 devices remain active

Initial Affected Population

Number of Confirmed Advisory Related Events

Estimated Remaining Active Population

Current Malfunction Rate (confirmed malfunctions over total population)